Mission

 

Be a member of R&D project teams to provide expert ADME & DMPK guidance across the non-clinical and clinical development of NBEs, including new drug modalities such as mRNA LNPs,  in a multidisciplinary environment. Drive ADME & DMPK profiling, bioanalysis, PK/PD, human dose predictions,  M&S or  other related deliverables, to advance biologic drugs  through early and late development up to health authority submissions.

 

Tasks and Responsibilities Represent the DMPK function in cross-functional teams or in collaboration with external partners,  to deliver data and drive informed decision-making aligned with project goals. Ensure that the proper flow of information between the project, the function, and key stakeholders is in place. Participation, performance, direction or outsourcing of studies to improve the knowledge of ADME/DMPK across non-clinical & clinical development Responsible for the bioanalytical needs (e.g. PK, ADA and Nab assays) to support non-GLP or GLP ADME/DMPK studies across drug development, as well as ensure adherence to global regulatory standards (e.g., FDA, EMA). Integrate the various bioanalytical and immunogenicity data to interpret PK. Contribute to the design of pre-clinical and clinical translational strategies and MIDD approaches in collaboration with non-clinical and Clinical departments. Ensure that PK, PK/PD, dose predictions or other related non-clinical or clinical PK deliverables are undertaken to best practice standard for study design and regulatory submissions. Provide high-quality data and presentations, both internally and to potential partners, to ensure regular progress updates on ongoing projects. Author high quality reports, including support to regulatory documents, such as  INDs, CTAs, MAA of BLA filings when needed. Evaluate external assets for clinical and nonclinical ADME/DMPK and clearly communicate findings and recommendations to stakeholders. Maintain an up-to-date knowledge of the relevant scientific literature as well as regulatory guidance and best practice. Education MSc/PhD in Pharmacy, Chemistry, Biochemistry, Biology, biomedicine or related Life Sciences Specific Knowledge Broad experience in the bioanalytical science for biotherapeutics. Expertise in immunogenicity testing  and/or related sciences required in both the preclinical and clinical stages of drug discovery/development. Excellent understanding of translational medicine aspects to connect preclinical/Clinical DMPK, which includes adequate knowledge of  Modelling&Simulation concepts. Comprehensive knowledge of regulatory requirements and guidelines related to NBE ADME/DMPK and strong capacity to de-risk drug submissions thought a deep understanding of the expectations of regulatory agencies.

 

 

Experience

7+ years of industry experience in the field of ADME/DMPK/Bioanalysis of biological molecules, such as NBEs, ADC, or other novel modalities.

Experience with mRNA LNPs modality will be highly valued.

Competencies Teamwork and personal leadership. Ability to work in a matrix environment, multi-task, meet deadlines and deal with evolving priorities. Strategic thinker with leadership skills and the ability to work collaboratively across various teams and disciplines. Capable of building and maintaining professional networks to support collaborative efforts. Fluent in both oral and written English, essential for effective communication and documentation. Excellent inter-cultural understanding. Values Care: we listen & empathize, we value diverse perspectives & backgrounds and we help each other succeed. Courage: we challenge the status quo, we take full ownership and we learn from our success & failures Innovation: we put the patient and customer at the center, we create novel solutions and we empower entrepreneurial mindsets.  Simplicity: we act decisively and avoid over-analysis, we understand why before we act and we are agile & keep things simple.